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This is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence
The aim of the project is to evaluate RRS with delayed RRO as an alternative for RRSO in BRCA1/2 gene germline mutation carriers with respect to ovarian cancer incidence. We hypothesize that postponement of oophorectomy and consequent menopause to the age of 40-45 (BRCA1) or 45-50 (BRCA2) compared to current standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) will not lead to a significant increase in ovarian cancer risk. PRIMARY OBJECTIVE: To evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence in BRCA1/2 gene germline mutation carriers. SECONDARY OBJECTIVE: Incidence of (pre)malignant findings in tubes/ovaries, perioperative morbidity and mortality, incidence of non-ovarian pelvic cancer, breast cancer, prophylactic breast surgery and uptake of risk reducing oophorectomy. EXPLORATORY OBJECTIVE: Estimate high grade serous (ovarian) cancer incidence for innovative and standard treatments in BRIP1, RAD51C, and RAD51D gene germline mutation carriers
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
WU St Louis
St Louis, Missouri, United States
Mount Sinai Health System
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lyndon Baines Johnson General
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
University of Washington
Seattle, Washington, United States
Start Date
May 10, 2022
Primary Completion Date
December 26, 2026
Completion Date
December 26, 2026
Last Updated
November 5, 2025
100
ESTIMATED participants
RIsk-Reducing Salpingectomy (RRS)
OTHER
Risk-Reducing Oophorectomy-RRO
OTHER
Risk-Reducing Salpingo-Oophorectomy-RRSO
OTHER
Lead Sponsor
M.D. Anderson Cancer Center
NCT05039801
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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